Addressing challenges in Drug Development and Quality Control with innovative solutions

Transcription

1 Addressing challenges in Drug Development and Quality Control with innovative solutions SYNOPSIS 16 May 2013, 9:30 am 3:00 pm Gd. Titan Centre (Theater Room) This seminar is designed for scientists in the generic pharmaceutical industry eager to learn about the latest optimized analytical methods to ease the challenges you face during the processes of drug testing to quality control to process monitoring. For generic pharmaceutical companies, there is an expansive and expensive gap between testing for variability in production and verifying product quality. The key to end-product profitability is found in the confidence that your formulations are of high quality and consistent throughout the entire commercialization process while meeting the standards of regulatory compliance. It is invaluable to be able to share pertinent information and experience through the clients we work with to provide insights to you. The presentations and discussions will introduce solutions to help you achieve: Productivity: Sensitive bio-analytical assays to increase efficiency and reduce costs Compliance: Learn about the latest compliance methodologies and validation to international regulatory standards Please join us on 16 May 2013, 9.30 am at Gd. Titan Centre (Theater Room) for a free seminar to discover how our innovative scientific practices can support you in enhancing operational efficiency of your laboratories.

2 AGENDA 9:30 9:45 Registration (Coffee Break) 9:45 10:00 Introduction Market Development Manager 10:00 10:45 How your CDS can help you to improve your Laboratory Compliance and increase laboratory productivity at the same time I Gede Widya Sputra Analytical Development Manager PT Kalbe Farma 10:45 12:00 USP Modernization Process and adopting Quality by Design in the development labs. Rina Lue Market Development and Application Specialist 12:00 13:00 LUNCH BREAK 13:00 14:00 Recent trends in Compliance Market Development Manager 14:00 15:00 Addressing the challenges in developing simple robust LC/MS/MS methods for bioanalysis/bioequivalence studies Jeremy Netto Senior Market Development & Application Specialist

3 THE SPEAKERS Rina Lue Market Development and Application Specialist, Chemistry and Separations Waters Solution Centre Rina Lue provides application and technical support to end users in areas of liquid chromatography and mass spectrometry as an Application Chemist with Waters. Her expertise includes designing and conducting product trainings for both internal and external customers. Prior to Waters, Rina has background in pharmaceutical research with Defense Science Organization (DSO) of Singapore and GlaxoSmithKline in UK. She obtained her Honours Degree and Master s Degree from the National University of Singapore. Her postgraduate work on protein microarray was featured in Nature Biotechnology and several reputable peer-reviewed journals. Rina has notably received invites to contribute in several book chapters relating to her research. In addition, her research project had been granted two US patents to protect the novelty of the data generated. Market Development Manager, Pharmaceutical & Life Sciences is part of the Waters Asia team as Market Development Manager for Pharmaceuticals and Life Sciences Market segment since February Krishna, a graduate in the field of Polymer Science with proficiency in Oracle database joined Waters India in May He began his career as Sales and Support Engineer and progressed to the Product Specialist of LC and MS. In 2009, Krishna assumed the role of the Regional Manager responsible for the newly formed North West region in India and led a team of 8 comprising of Sales, Application Lab and Customer Assurance teams to manage the entire region's operations and sales. He, along with his team, has partnered the top generic pharmaceutical players in India, collaborating and guiding them in areas of method development, regulatory compliance and user trainings.

4 Jeremy Netto Senior Market Development & Application Specialist Clinical, Pharmaceutical & Life Sciences Waters Solution Centre Jeremy joined Waters Singapore in 2011 as an R&D Chemist developing application solutions for the pharmaceutical and life sciences arena including patentable inventions such as multidimensional separation techniques. Jeremy s current role takes him through South Asia with a prerogative to address and develop this fast growing region in the areas of drug discovery and development as well as forensic toxicology. Jeremy s approach to drive customer success and enrich customer experience is to lead them through the entire process of scientific consultations, sample analysis/ demonstrations, application trainings to technical support. He also presents at both regional and international seminars and conferences. In addition to over 8 years of experience in chromatographic and mass spectrometric techniques, Jeremy's diverse background ranges from academic majors in biotechnology, molecular biology, forensic biology and toxicology, biomedical science and pharmaceutical chemistry to professional experience as an analytical method developer in Pfizer and a university lecturer in pharmacology. Jeremy Netto obtained his PhD in Pharmaceutical Chemistry from Murdoch University, Australia. He lectured in Pharmacology at MDIS/University of Bradford, in Singapore for a year before joining Waters. His doctoral studies focused on various chromatographic (LC & GC), mass spectrometric (IT, QqQ, ToF) technologies to the study of drug metabolism and pharmacokinetic mechanisms of pharmaceuticals, namely metabolite identification and bioanalysis. I Gede Widya Sputra Analytical Development R&D PT Kalbe Farma Gede is the Analytical Development Manager with PT Kalbe Farma Tbk. Gede received his Apothecary degree from Airlangga State University with major in Pharmaceutical Industry. He has more than 10 years of experience with Analytical Method Lifecycle, specializing in method development, method validation, method transfer and continuous improvement. Gede possesses hands-on experience in various analytical instruments ranging from spectrometry (UV-Vis Spectrometry, FTIR) to chromatographic family (TLC-Densitometry, HSGC, HPLC, UPLC and UPLC MS/MS) including CDS specifically the Empower Chromatographic Data System. Gede s area of interest includes application of QbD concept to Analytical Method

5 Development. His recent works focus on studies of extractable and leachable as well as large molecule characterization.